Review Of The US FDA's E-cigarette Enforcement Throughout The Year: Diverse Enforcement Measures Across The Entire Chain, With A Focus On Kikner And Ai Miracle

Review of the US FDA's e-cigarette enforcement throughout the year: Diverse enforcement measures across the entire chain, with a focus on Kikner and Ai Miracle

2Firsts sorted out the FDA's enforcement of e-cigarettes in the United States throughout 2024. The FDA's enforcement showed four major characteristics, among which Kikna and Aiqiqi have become the focus of enforcement.
Statement:

[1] This article is based on the sorting and summary of public information. Due to the limited collection capacity, there may be incomplete data.

[2] The summary of enforcement phenomena in this article does not represent any official conclusion.

[3] For the expression and understanding of enforcement information, please refer to the official release.

On December 5, the US FDA announced that it had issued warning letters to 115 physical retail stores because these merchants were punished for selling unauthorized e-cigarette products, including Geek Bar Pulse, Geek Bar Skyview, Geek Bar Platinum and Elf Bar. (The US FDA issued warning letters to 115 merchants. Geek Bar and Elf Bar brands were named)

This action marks that the FDA has taken 20 actions against illegal e-cigarettes in 2024 (incomplete statistics). Looking back at these FDA enforcement actions, we can find that the focus of enforcement is on illegal e-cigarette products that attract teenagers and are also products that have not obtained a marketing authorization (PMTA).

Characteristics of FDA's enforcement against illegal e-cigarettes in 2024

2Firsts sorted out the FDA's enforcement in 2024 and summarized the following characteristics:

1. Full-chain crackdown: FDA's enforcement against illegal e-cigarettes covers import and export customs, wholesale and retail links. In connection with the news that Congressman Raja Krishnamoorthi proposed to investigate illegal e-cigarette manufacturers in China in early December, it can be seen that the US crackdown on illegal e-cigarettes intends to cover the entire industry chain.

2. Targeting key manufacturers and key brands: Sorting out FDA's actions, we can find that many enforcement actions have targeted brands under GeekVape and Heaven Gifts, such as Geek Bar and Elf Bar. Newly developed brands of the above companies (such as EB Design) are also included in the enforcement targets.

In many FDA enforcement announcements (no less than 8, according to incomplete statistics from 2First), the above-mentioned brands were directly named (or even the only ones named), which shows that the above two companies have become the focus of FDA enforcement.

FDA's enforcement announcement on December 5, 2024, Geek Bar is specifically mentioned in the title | Source: FDA website

3. Multi-agency collaborative enforcement: FDA works with the U.S. Customs and Border Protection (CBP) and the Department of Justice to take joint actions against cross-border trade in illegal e-cigarette products, such as the major case of seizing 3 million illegal e-cigarette products in October 2024. Congress and relevant lawmakers have also repeatedly urged the FDA to strengthen supervision and enforcement of e-cigarettes in different ways.

FDA's enforcement announcement on October 22, 2024, the U.S. FDA and Customs seized 3 million illegal e-cigarette products including GEEKBAR | Source: FDA website

4. Diversified enforcement methods: FDA has adopted a variety of methods to enforce the law, including:

Warning letter: Covering retailers on a large scale, urging them to immediately stop selling illegal products.

Fine: Civil money penalties are imposed on violators to curb illegal sales. For example, a fine of $20,000 was imposed on a non-compliant retailer.

Product seizure: Conduct supervision and law enforcement in conjunction with the customs department at the customs stage, seize illegal products, and combat illegal trade.

FDA emphasizes that approval must be obtained for listing

In October of this year, the FDA responded to an email from 2Firsts asking about the marketing license of e-cigarette products and reiterated that only 34 e-cigarette products have been licensed for legal sale in the United States. The FDA also provided 2Firsts with details of the 34 products.

List of 34 products that have passed PMTA | Source: U.S. FDA